Tornier HRS Max parts: 1 — Class II medical device recall Z-1769-2026
Ongoing recall by Tornier, Inc, reported 2026-04-15, distributed nationwide. Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the To
| Recall number | Z-1769-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier, Inc, Bloomington, MN, United States |
| Recall initiated | 2026-03-05 |
| Classified | 2026-04-03 |
| Reported by FDA | 2026-04-15 |
| Distributed | Nationwide (US) |
| Quantity | 233 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00840338603623, 00840338603630, 00840338604033 |
| Lot numbers | AZ0124351, AZ0124352, AZ0224351, AZ0224352, AZ0324352, AZ0424352, AZ0524351, AZ0524352, AZ0624352, AZ0724351, AZ0724352, AZ0824352, AZ0924351, AZ0924352, AZ1024352 |
| Model numbers | ARS10252, ARS1041101, ARS1041102 |
Product
Tornier HRS Max parts: 1. TORNIER HRS Max Tuberosity Body Lat Coat, Small, Cat. No. ARS1041101 2. TORNIER HRS Max Tuberosity Body No Coat, Small, Cat. No. ARS1041102 3. TORNIER HRS Max Trial, Cat. No. ARS10252
Reason for recall
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1769-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.